CREST GUM AND ENAMEL REPAIR INTENSIVE CLEAN- stannous fluoride paste, dentifrice

Crest Gum and Enamel Repair by

Drug Labeling and Warnings

Crest Gum and Enamel Repair by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, Honeywell Specialty Chemicals Seelze GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% w/v fluoride ion)

Purposes

Anticavity, antigingivitis toothpaste

Uses

• aids in the prevention of cavities
• helps prevent gingivitis
• helps interfere with the harmful effects of plaque associated with gingivitis
• helps control plaque bacteria that contribute to the development of gingivitis

Warning

Keep out of reach of children under 12 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
• do not swallow
• children under 12 yrs. of age: ask a dentist

KEEP OUT OF REACH OF CHILDREN

Other information

• products containing stannous fluoride may produce surface staining of the teeth
• adequate toothbrushing may prevent these stains which are not harmful or permanent and may be

removed by your dentist

• this Crest is specially formulated to help prevent staining
• see your dentist regularly

Inactive ingredients

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 116 g tube in carton

Crest®

FLUORIDE TOOTHPASTE FOR

ANTICAVITY AND ANTIGINGIVITIS

Gum

&

ENAMEL

REPAIR
INTENSIVE CLEAN

Clinically Proven to help
Reverse Gingivitis.
Repairs Weakened Enamel.

NET WT 4.1 OZ (116 g)

INGREDIENTS AND APPEARANCE

CREST GUM AND ENAMEL REPAIR  INTENSIVE CLEAN
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-505
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-505-41	1 in 1 CARTON	04/01/2018
1		116 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-505-85	1 in 1 CARTON	04/01/2018
2		24 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)